Twitter chat: Americans are pessimistic about the opioid crisis. What does that mean for a solution?

Twitter chat: Americans are pessimistic about the opioid crisis. What does that mean for a solution?

http://www.pbs.org/newshour/rundown/twitter-chat-americans-pessimistic-opioid-crisis-mean-solution/

A recent PBS NewsHour/Marist poll showed that Americans consider opioid addiction a “serious and growing” problem. And they don’t foresee the crisis improving without intervention.

The poll, released in partnership with the Marist Institute for Public Opinion, also showed Americans are largely split on who is to blame for the epidemic — the government, the healthcare field or pharmaceutical companies — and are even less sure who should be responsible for solving the crisis. They all did agree, however, that Congress and President Donald Trump aren’t doing enough to fix the problem.

To discuss additional poll findings as well as how this insight can be used to help end the addiction crisis, the PBS NewsHour will host a Twitter chat at 1 p.m. ET Oct. 5 with NewsHour’s data producer Laura Santhanam (@laurasanthanam) and Andrew Kolodny, the co-director of opioid policy research at the Heller School for Social Policy and Management (@andrewkolodny).

Find the rest of our America Addicted series, which examines the opioid crisis, here.

Have questions? Tweet them to #NewsHourChats

Cigna says it won’t cover OxyContin prescriptions through employer plans

Cigna says it won’t cover OxyContin prescriptions through employer plans

www.statnews.com/2017/10/04/cigna-opioids-oxycontin/

The health insurer Cigna on Wednesday announced it will no longer cover OxyContin prescriptions for customers on its employer-based health plans, the second major announcement in two weeks from an industry group billed as an effort to slow the opioid epidemic.

Cigna also announced its intent to reduce opioid use among its consumers by 25 percent by 2019. Insurance consumers who have started OxyContin use for cancer or hospice care are exempt from the policy change.

To fill the void left by OxyContin’s removal, the insurer has turned to Xtampza ER, which it calls an “oxycodone equivalent with abuse deterrent properties.” The drug is already a preferred brand on the insurer’s drug lists, but Cigna announced it was entering into a new value-based contract with Xtampza manufacturer Collegium Pharmaceutical that will penalize Collegium “if the average daily dosage strengths exceed a certain threshold.”

The pill’s formulation, Cigna said, allows it to maintain a consistent dosage strength even if crushed, chewed, or otherwise manipulated.

OxyContin’s manufacturer, Purdue Pharma, said its drug was formulated with some of the same properties as the drug Cigna intends to replace it with.

“We believe that patients should have access to FDA-approved products with abuse deterrent properties,” Robert Josephson, Purdue’s executive director for communications, wrote in an email to STAT. “Unfortunately, Cigna’s decision limits the tools prescribers can use to help address the opioid crisis as both products are formulated with properties designed to deter abuse.”

One expert, however, said that Cigna’s decision would likely not have a substantial impact on deterring opioid misuse. Dr. Wallid Gellad, the co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said the biggest shift was not in the drugs Cigna was willing to prescribe but in the financial arrangements a manufacturer had agreed to.

“It looks like part of the reason is they signed a deal with the maker of this other product [to cover some costs] if the dose is higher than a certain amount,” Gellad said. “This other drug is the same thing — it’s a long-acting version of oxycodone. Whether there are subtle differences, I don’t know, none that I’m aware of.  But this does not seem to me to be a decision that’s based on doing something about the opioid crisis.”

It is the second policy shift in as many weeks from industry groups — PhRMA CEO Stephen Ubl announced last week at a meeting of the presidential commission on the opioid crisis that his group now supports a seven-day limit on opioid prescriptions. The group called the policy “the right thing to do” in subsequent paid advertisements on Twitter.

Purdue’s CEO, Craig Landau, appeared with New Jersey Gov. Chris Christie, Ubl, and NIH Director Francis Collins at a mid-September event in Trenton, N.J., in announcing a public-private partnership between the NIH and drug manufacturers, listing dual goals of developing new medication-assisted treatment alternatives and developing non-addictive alternatives to opioid pain medicines.

This is a interesting listen and perspective

If you listen to this 7 minute video from a Canadian citizen about the USA’s 2nd Amendment  and the reason behind it justification.

BUT.. if you insert opiates and the war on drugs … there is some very similar “facts” about the bureaucratic mindset as to  how the “war on drugs” need to be continues and opiates used to treat pain .. especially long term use should be banned.

And apparently “our friends” at the CDC has tried to get involved with gun ownership .. just like they have came out about use use of opiates in treating chronic pain.

Too bad the chronic pain community is not well organized or funded as the NRA is… While they say that you can’t “buy” a member of Congress.. it does appear that many can be INFLUENCED with large donations to their re-election campaign fund.

DEA Agents Sold Opioids, Stole Cash, and Falsely Identified Drug Suspects, Say Feds

Karl Newman mugshotDEA Agents Sold Opioids, Stole Cash, and Falsely Identified Drug Suspects, Say Feds

Four former Drug Enforcement Administration (DEA) operatives face federal corruption and conspiracy charges after allegedly engaging in all sorts of shady behavior, from selling drugs themselves to lying under oath, falsifying records, falsely identifying drug suspects, accepting bribes, and stealing cash and other property from the people they arrested. In at least one instance you can find out more about here, their behavior led to someone being wrongly imprisoned for more than two years.

The dirty drug warriors—special agent Chad Scott, with the DEA since 1997, and former task force officers Rodney Gemar, Karl Newman, and Johnny Domingue—worked with the DEA’s New Orelans Division. Gemar and Newman also work for local law enforcement agencies.

In an indictment unsealed this week, Scott, Newman, and Gemar—a Hammond Police Department officer since 2004 and DEA Task Force Officer since 2009—are accused of seizing money and other property from those they arrested and then keeping it for themselves. (Notably, the feds do not frame this as theft from the suspects but as embezzling funds from the DEA.) This went on for at least seven years.

Scott is also accused of accepting $10,000 from a defendent in a federal criminal case in exchange for recommending that prosecutors seek a reduced sentence and, in another case, tampering with witness testimony.

Scott allegedly coerced Frederick Brown (a defendent in his own drug case) “to falsely testify that Jorge Perralta was present during drug transactions between Edwin Martinez and [Brown], when in fact Frederick Brown had never seen Jorge Perralta during his drug transactions with Edwin Martinez.” Scott reportedly offered his own false testimony in the case as well.

The DEA agent claimed that it was Brown who initially brought up Perralta when talking about people who were around during deals and might be Martinez’s supplier, referring to Perralta not by name but as “the little Mexican guy.” Scott said that he showed Brown a photograph of Perralta on his phone, and that Brown confirmed this was the dude he had seen during drug deals.

An arrest warrant was issued, and Scott went to Houston to help police there arrest Perralta for conspiracy to distribute heroin and cocaine. Perralta’s phone was seized, he was taken into custody, and—without even being allowed to contact his parents or girlfriend—he was whisked away to Louisiana. That was in March 2015.

After nearly two and a half years behnd bars, Perralta was released in August 2017 and all charges against him were dismissed.

Brown had never brought up Perralta on his own, say prosecutors in their indictment against Scott. And when shown a picture of Perralta, Brown said that he had never seen him.

Both Scott and Gemar were arrested on October 1 and released on bond the next day.

Newman and Domingue were arrested in 2016. According to federal prosecutors, Newman seized and sold thousands of dollars worth of cocaine and oxycodone. Some of these drugs he seized from a woman identified as R.G. “by means of actual and threatened force, violence, and fear of injury…to R.G.’s person and the persons of her family.”

Domingue is accused only of falsifying records related to this illegal drug seizure. His trial is set February 2018.

Newman has agreed to plead guilty to one count of “conspiracy to convert property” and one count of using a gun in furtherance of a crime of violence, in exchange for prosecutors dropping the other charges against him. He faces fines of up to $500,000 and possible life in prison, with a mandatory minimum sentence of at least five years.

CVS Health’s website and mobile apps could be a violation of federal disability laws.

CVS Pharmacy Inc.’s website and mobile apps do not ensure blind users can access services and could be a violation of federal disability laws.

http://www.therecorder.com/id=1202799612711/CVS-Cant-Boot-Suit-Challenging-Websites-ADA-Compliance?mcode=1202617072607&curindex=0&slreturn=20170904160043

A California federal judge’s ruling this week keeps alive a suit that alleges CVS Pharmacy Inc.’s website and mobile apps do not ensure blind users can access services and could be a violation of federal disability laws.

Uncertainty over the scope of ADA protections has only increased in recent years, sparking a wave of lawsuits that seek to push the reach of the law beyond entrance ramps and bathroom access for people with disabilities. This week, the U.S. Supreme Court turned away an appeal that sought Coca-Cola Co. and other companies to equip vending machines for use by blind people, agreeing with a lower court that the ADA’s protections for “places of public accommodation” does not extend that far

In the CVS case, U.S. District Judge Michael Fitzgerald of the Central District of California ruled in favor of blind users in Reed v. CVS Pharmacy, Inc. and said that the business did not comply with the U.S. Justice Department’s directive to ensure that disabled individuals have equal access to websites. He dismissed the stance that CVS, like many businesses addressing this issue, took that the users were asking the company to abide by non-governmental guidelines.

Joe Manning, a lawyer in Newport Beach, California, who represents plaintiff Kayla Reed in the CVS case, as well as several other clients who are fighting in similar cases for website accessibility, said he believes this is the first court overrule a company’s motion to dismiss an ADA claim related to a mobile app.

 
A lawyer for CVS—Mark Eisen of Benesch Friedlander Coplan & Aronoff—was not immediately reached for comment. The company will file its answer to the order by Oct. 23, according to court documents.

In the California court ruling, Fitzgerald concluded: “A determination of liability does not necessarily require the court to master complicated web standards, but rather asks the court to make exactly the same sort of accessibility determinations that it regularly makes when evaluating the accessibility of physical locations.”

Judges in other cases this year have reached differing outcomes, offering no clear guidance to companies. Meanwhile, the Justice Department under President Donald Trump has apparently sidelined the issue. “This is a significant event in the course of the federal government’s messaging on this issue,” the law firm Pepper Hamilton wrote in an advisory in April.

Manning represents plaintiff Guillermo Robles in two nearly identical cases in California federal court against Domino’s Pizza LLC and against Pizza Hut, owned by Yum! Brands Inc. Another case in Florida, against grocery chain Winn-Dixie Stores Inc. also shows the discordant approach courts have taken to resolve questions about access for the blind to websites.

The recent cases against CVS, Domino’s and Winn-Dixie resulted in opposing rulings. The Dominos and Winn-Dixie cases are heading to respective appeals court in California and Florida. In the Pizza Hut case, U.S. District Judge Otis Wright II issued a stay and permitted the U.S. Justice Department to intervene and provide clarity about the scope of the ADA. The request was the first time a judge took such action.

Since 1996, the Justice Department has said the ADA applies to the web, but there have not been specific rules in place. In 2010, under the Obama administration, there was a notice of proposed rulemaking to determine the existing obligation for websites to have stricter rules, but no rules were issued.

In July, the Justice Department under U.S. Attorney General Jeff Sessions formally moved “website regulation” to the inactive list of issues that it plans to pursue in the near and long-term.

There is also a split among federal appeals court decisions over whether a business that does not have a brick and mortar location can be considered a place of public accommodation, covered by the ADA.

Successful legal actions have been taken against companies such as Apple, Target and Amazon. Certain protocols have been put in place to make it easy for developers to incorporate accessibility features.

There is a universally used system, the Web Content Accessibility Guidelines, to make websites available to blind and visually-impaired people. A case against Apple in 2008 resulted in a settlement between advocates and the Massachusetts Attorney General, requiring iTunes to be accessible to people who are blind. Following this case, Apple developed guidelines for developers to incorporate practices as well.

Many businesses argue that—unlike for websites—there are specific compliance measures they know they need to take with requirements under the ADA. Internet-specific guidelines have not been laid out, and investments made in new technology could still result in more lawsuits. Companies generally say they want to wait for specific guidelines from the federal government before addressing how far the ADA reaches to the web.

Medical cannabis can help reduce our nation’s pain epidemic.

Medical cannabis can help reduce our nation's pain epidemic.Medical cannabis can help reduce our nation’s pain epidemic

http://thehill.com/opinion/healthcare/353482-medical-cannabis-can-help-reduce-our-nations-pain-epidemic

On Wednesday, Sept. 27, the president’s Commission on Combating Drug Addiction and the Opioid Crisis, lead by Governor Chris Christie (R), held its third meeting entitled: Innovative Pain Management and Prevention Measures for Diversion.

The agenda, which was not released until the day it was scheduled, included testimony from 10 invited organizations, all of which were from the pharmaceutical industry. Consequently, the tone of the meeting came off as a commercial by each of the companies asking for government assistance in getting their medications to market more quickly.

One in three Americans suffer from chronic pain and one in ten have experienced severe pain every day for three months or more. If effective pharmaceutical alternatives to opioids for chronic pain already exist, why aren’t we already using them?

While it is quite possible that innovations from the pharmaceutical industry could be helpful in providing health care practitioners with alternative treatments to chronic pain, these innovations can take years to develop. All of the medications currently on the market the presenters discussed also include a laundry list of side-effects such as nausea, anxiety, insomnia, and impotence. Why not explore what millions of Americans are already using successfully as an alternative or adjunct treatment to pain, with little to none of the side-effects associated with pharmaceutical treatments, medical cannabis?

If the intent of the commission is to truly look at innovations in pain management, then why were pharmaceutical approaches the only ones discussed on this panel? There are numerous non-pharmaceutical interdisciplinary approaches and therapies to pain management that were not discussed at all, and a glaring omission was medical cannabis.

Dr. Francis Collins, director of the National Institutes of Health expressed the need to accelerate the pace of how medicines that may help with chronic pain are researched and obtain FDA approval. However, there was no mention of accelerating research into using medical cannabis to treat chronic pain.

Americans for Safe Access, the country’s largest patient-focused medical cannabis advocacy organization, requested to be included in today’s meeting to provide testimony, but was denied a seat at the table. Innovation is typically associated with new ideas or creativity in application. Although medical cannabis has been used as a treatment for pain for thousands of years, a concerted effort in applying medical cannabis as a tool to help fight the opioid crisis is not only innovative, but has great potential. Ignoring this potential is a grave error by this commission.

Why should medical cannabis be considered a tool to fight the opioid crisis? Thirty states, including those most negatively impacted by the opioid crisis such as West Virginia, New Hampshire, and Ohio, and Washington, D.C. all have medical cannabis programs. Many of these states allow cannabis delivery to be used to treat chronic pain. Some others use vape pens. Check out this blog post if you think your ooze pen isn’t working or broke.

A study in the Journal of the American Medical Association indicated that in states with medical cannabis programs, there has been a 25 percent reduction in opioid related deaths. This study also showed a 13 percent decrease in hospitalizations from opioid related causes. In a survey of nearly 3,000 pain patients, 93 percet preferred medical cannabis over opioid therapies for pain management. In addition to the data, there are thousands of personal stories of patients who have been able to reduce the number of opioids they take or come off opioid therapies altogether by using cannabis.

The National Academies of Science, Engineering, and Medicines revealed strong clinical evidence that cannabis is highly effective in treating chronic pain. The National Institute on Drug Abuse (NIDA) has indicated that medical cannabis legalization might be associated with decreased prescription opioid use and overdose deaths.

A NIDA funded analysis showed that a areas with a greater number of medical cannabis dispensaries were associated with decreases in opioid prescribing, in self-reports of opioid misuse, and in treatment admissions for opioid addiction. This past week the National Institutes of Health (NIH) indicated that medical cannabis “might be effective for chronic…primarily for neuropathic pain patients.”

Cannabis alone will not end the opioid crisis. Cannabis will not and should not replace the prescribing of opioids or other pain medications. And we recognize, that cannabis, like any other medicine has side effects. But we can not continue to ignore the usefulness of medical cannabis in reducing our nation’s pain epidemic. Cannabis is one of many tools that can help fight this epidemic. And it is a tool that this commission should consider carefully and seriously.

Steph Sherer is founder and executive director of Americans for Safe Access (ASA). ASA is the largest national member-based organization of patients, medical professionals, scientists, and concerned citizens promoting safe and legal access to cannabis for therapeutic use and research. Alongside the American Herbal Products Association (AHPA), she has created the first industry standards in the areas of Distribution, Cultivation, Analytics, and Manufacturing, Packaging, and Labeling.

 

Now we know why M&M had no interest in denial of care for CPP – going after “DEEPER POCKETS” ?

Morgan & Morgan to Help Kentucky AG in Fight to End Opioid Crisis Hero ImageMorgan & Morgan to Help Kentucky AG in Fight to End Opioid Crisis

https://www.forthepeople.com/blog/kentucky-opioid-crisis

We are proud to announce that the Kentucky Attorney General’s office has selected our law firm to lead litigation against the major players responsible for creating the opioid crisis, a drug epidemic that has caused immeasurable heartbreak and suffering for families in the state.

“The people of Kentucky need justice to be served for this horrible epidemic, and that’s what Morgan & Morgan is all about,” John Morgan said.

Morgan & Morgan’s Government Action Group, led by attorneys James Young and Greg Stumbo, will join the legal team established by Attorney General Andy Beshear to investigate potential litigation against drug manufacturers, distributors, and retailers that have contributed to — and profited from — the opioid crisis through the illegal marketing and distribution of opioids in Kentucky.

For Morgan & Morgan founder John Morgan, who grew up in Lexington, getting justice for those who have suffered through the opioid epidemic in his home state is a personal matter.

“The people of Kentucky need justice to be served for this horrible epidemic, and that’s what Morgan & Morgan is all about,” John Morgan said. “We’ve tried more cases than any other firm, and our attorneys aren’t afraid to stand up to these pharmaceutical companies in front of a jury. They picked a fight with David, but Goliath just showed up.”

A Brief History of the Opioid Crisis

The problem of prescription and non-prescription opioid abuse began in the early 2000s and has spiraled into a full-blown crisis since then. Sales of prescription opioids in the U.S. nearly quadrupled from 1999 to 2014, according to U.S. Centers for Disease Control and Prevention. Likewise, the number of overdoses involving deaths since 1999 have also quadrupled. Many believe the aggressive marketing and overprescription of opioids to vulnerable patients is to blame for the crisis.

Those who first become addicted to pills prescribed to them by their doctor to manage pain after an accident or surgery often turn to heroin as their addiction grows. Everyday, over 90 Americans die from overdosing on opioids, according to the CDC, and these deaths are disproportionately affecting rural America and the Rust Belt.

“Nearly 80 percent of heroin users first become addicted through prescription pills,” Beshear said in a press release. “If we can reduce opioid prescriptions and use other forms of pain management treatment, we will slow or even reverse the rate of addiction.”

Our Experience in the Fight Against Opioids

One of the reasons our firm was chosen by the Attorney General to aid in the fight against opioid abuse in Kentucky is our previous experience in handling litigation against the opioid manufacturers and distributors who push these highly addictive drugs.

Last year, Morgan & Morgan filed a lawsuit against major drug distributors McKessen Corp., Cardinal Health, and AmerisourceBergen Drug Co. on behalf of McDowell County, West Virginia — a county with some of the highest overdose death rates in the country. This was the first lawsuit filed in the state against the three drug giants, which supplied more than half of West Virginia’s opioids at the time.

We are honored to use our opioid litigation experience to help the Attorney General’s office hold any responsible parties accountable for their role in contributing to the opioid epidemic. We look forward to bringing justice to the families of Kentucky affected by the crisis.

 

Canada’s Opioid Guidelines Let Her Die Without Dignity

Canada’s Opioid Guidelines Let Her Die Without Dignity

http://www.huffingtonpost.ca/marvin-ross/canadas-opioid-guidelines-let-her-die-without-dignity_a_23204951/

Our response to overdose deaths is to target pain patients and their doctors, when most know that this is not the source of the problem.

The last six months of her life before she passed away last week were spent in misery thanks to the new opioid-prescribing policies being forced in Canada. Catherine, as she was known on the Roy Green Show, died last week. She was a frequent guest on Green’s show talking about how the new Canadian opioid-prescribing guidelines have impacted her. I’ve been writing about this here for quite some time.

Catherine first became ill in 2010 with a blood disorder that resulted in her body retaining iron. It caused her terrible constant pain and effected her liver, her stomach lining and her heart. Her family doctor treated her pain with a combination of long term opioids supplemented with short-acting opiods for breakthrough pain. She described to Roy that her pain level was kept to a three or four out of 10, and she was able to maintain a reasonable quality of life and to work.

Martin Barraud

When the 2017 guidelines for opioid use in non-cancer pain were introduced, her doctor was ordered by his regulatory agency to reduce her medications by 50 to 60 per cent and her pain level shot up to a seven or nine. She was no longer able to work or to function. She had been on a wait list for a pain clinic for two years and was told it would be another year before she could see someone. Before her unfortunate death, she was struggling greatly with pain which her doctor was prevented from ameliorating as he had done in the past.

The guidelines do not tell doctors to force patients off opioids, but that is what is happening. Jason Busse, the chair of the guideline committee who is an associate professor of anaesthesia (a chiropractor not an MD) and researcher at McMaster University, assured Green that the guidelines do not mandate that and he said that it was dangerous to do so. However, he did admit that doctors are under pressure to reduce opioid use amongst their patients.

His colleague on the guidelines committee, Dr. David Juurlink from the University of Toronto, agreed that we will not fix the addiction problem in Canada by cutting people off opioids — instead, he insisted cutting them off will make things worse for them.

So, why are we doing exactly that?

Our response to overdose deaths is to target pain patients and their doctors, when most know that this is not the source of the problem.

The main reason seems to be the false belief that doctors prescribing opioids to patients are the cause of the large increase in addictions and overdose deaths. As I’ve pointed out before, this is not the case. In his interview linked above, Dr. Busse estimates that maybe five per cent of people prescribed opioids become addicted, while Dr. Juurlink thinks it is maybe 10 per cent. I’ve argued that it is much lower than that. Dr. Busse suggested that only about five per cent of prescribed opioids are diverted to illegal use.

A recent report shows that Hamilton has one of the highest death rates for opioids in Ontario, but one of the lowest prescription rates for opioids. The deaths are caused by illicit drugs. And Dr. Busse told Roy Green that experts have no idea how many of these deaths resulted from drugs prescribed to people, those that are diverted from legitimate prescriptions or drugs from illicit sources.

Dr. Thomas Kline recently wrote that the idea that prescription drugs cause addiction is nothing but a myth and that opioids are the only drugs that ease pain. Journalist Nick Bilton — who wrote American Kingpin about the founder of the Silk Road, a drug-selling website on the deep dark web — points out much of the deaths are attributable to purchases on the web. The chart on page 315 showing the enormous increase in deaths from synthetic drugs correlates with the revenues from that website. Both took off at about the same time. Bilton noted that 20 per cent of respondents who were asked where they got their drugs claimed they got them off the internet in the first year that website started up. It is likely much higher now.

Our response to overdose deaths is to target pain patients and their doctors, when most know that this is not the source of the problem. People have pain, we have the resources to deal reasonably well with that pain and it is inhumane to do what is being done. For politicians, it is a seemingly simple (but wrong) solution to demonstrate that they are doing something.

Getty Images/iStockphoto

There may, however, be another reason amongst some doctors which was explained by Dr. Juurlink and it comes down to a bias against opioids, for whatever reason. Juurlink explained to Green that there are a lot of people on opioids who think they are doing well but really aren’t. “They are being harmed in ways that they do not appreciate,” he said.

When my doctor gives me medicine, I know if it works. If it has side-effects, I assume they are known. For the pain patient, opioids take most or all of the pain away and you have no or few ill effects. But Juurlink thinks that is because you do not know what is really happening to you. I suspect that he is talking about a condition called opioid-induced hyperalgesia. For some people, taking high doses sensitizes you and you get more pain rather than less. Fine — maybe for some, but if you are taking the meds and your pain keeps getting worse, then you go to the doctor and tell him/her. It could be hyperalgesia or it could be tolerance requiring a higher dose. Regardless, the entire concept is highly controversial and some question the validity of the studies

In my opinion, Dr. Juurlink’s comments reflect a considerable arrogance — “You may not know it is not good for you, but I’m a doctor and I know better.” This attitude has no place in modern medicine. What we are seeing, again in my opinion, is a horrible experiment playing with people’s lives. Maybe overdose deaths will decline if we attack legitimate pain patients. Let’s see.

People are suffering with this opioid experiment and dying without any dignity. It is time to end it.

 

When is ACLU going to sue over chronic pain pts being denied care ?

ACLU sues to challenge FDA limits on access to abortion pill

http://www.miamiherald.com/news/article176783321.html

The American Civil Liberties Union sued Tuesday in a challenge to federal restrictions that limit many women’s access to the so-called abortion pill.

The lawsuit, filed in U.S. District Court in Hawaii, targets long-standing restrictions imposed by the Food and Drug Administration that say the pill, marketed in the U.S. as Mifeprex, can be dispensed only in clinics, hospitals and doctors’ offices. The lawsuit contends the drug — used for abortions up to 10 weeks of pregnancy — should be made available by prescription in pharmacies across the U.S.

“The abortion pill is safe, effective and legal. So why is the FDA keeping it locked away from women who need it?” said Julia Kaye, an attorney with the ACLU Reproductive Freedom Project. “The FDA’s unique restrictions on medication abortion are not grounded in science — this is just abortion stigma made law.”

The restrictions have been in place since the drug was approved for use in the U.S. in 2000. They stipulate that Mifeprex may not be sold in pharmacies and that all providers of the drug undergo a special certification process.

The FDA issued new guidelines for the use of Mifeprex last year, and said at the time that the restrictions continue to be necessary to ensure safe use of the drug.

  The FDA confirmed this week that the agency’s position has not changed since then. Regarding the lawsuit, it said the agency does not comment on pending or ongoing litigation.

The suit was filed on behalf of three health care associations and a physician, Graham Chelius. He works on the Hawaiian island of Kauai, which currently has no abortion providers.

Chelius, a family medicine doctor, says he is qualified and willing to provide medication abortion, but is unable to stock the abortion pill at the hospital where he works because of objections from some colleagues. As a result, he says, his patients must carry an unwanted pregnancy to term or make a 300-mile round trip flight to another island to get an abortion — boosting costs and sometimes delaying the procedure by several weeks. This could be avoided if the pill were available at pharmacies on Kauai.

The lawsuit is supported by the American Congress of Obstetricians and Gynecologists. Its CEO, Dr. Hal Lawrence, said there is no medical justification for the FDA restrictions.

According to a commentary earlier this year in the New England Journal of Medicine, 19 deaths have been reported to the FDA among the more than 3 million women who have used Mifeprex in the U.S. since 2000, a mortality rate lower than for pregnancy-related deaths among women.

The commentary suggested that lifting the FDA restrictions would likely increase the number of doctors willing to prescribe Mifeprex, since they would no longer have to stock the drug in their office and no longer have to be on a list of certified abortion providers. Easing the rules also might help make medical abortion more available via telemedicine to women in rural areas who live far from the nearest abortion facility, said the 10 co-authors, who included doctors and academics from Stanford, Princeton and Columbia universities.

According to the latest federal figures, medical abortions — generally a two-pill regimen using Mifeprex and the drug misoprostol — accounted for about 22 percent of abortions in the U.S. in 2013. Surgical procedures accounted for nearly all the other abortions.

Women using the pill generally take it in the privacy of their home. Noting that, Kaye said the legal case “is primarily about where a woman must be standing when she’s handed the abortion pill that’s been prescribed to her.”

“The FDA restriction defies common sense,” she said. “There’s no medical issue in whether she’s handed the pill at a pharmacy or at a clinic.”

There is precedent for a federal court to overturn FDA restrictions. In 2013, a federal judge in New York ordered that the most common version of the morning-after pill must be accessible over-the-counter for all customers of all ages, instead of requiring a prescription for girls 16 and younger.

At any point in time there is ONE PERSON addicted to Rx opiates and 22 ADDICTED TO ALCOHOL ?

FDA Commissioner Scott Gottlieb announces new educational requirements for drug makers.

BREAKING: FDA Issues New Demand To Doctors As Epidemic Reaches New Levels

At any given moment, approximately 2 million Americans are addicted to prescription painkillers. This can occur from them being over-prescribed painkillers or using them well beyond the scope of regular use.

Opioid addiction has become enough of an issue in the United States that the Food and Drug Administration (FDA) has taken a harder stance on education tied to the use of this class of drugs. Recently the FDA notified drug makers about the need to increase educational programs for doctors and at this point not including education for physicians is no longer optional.

The focus of this new educational component is the immediate release opioids that are currently made by large drug companies in the United States. Although there are many legitimate uses for this class of pain medication, there are also many forms of the drugs that feed the addiction. Deaths from opioid addict take the lives of about 33,000 people each year in this country. The opiate addition is now described as being an epidemic in this country.

To encourage responsible use of painkillers, the FDA is creating a new requirement for education via the drug makers. Although there is not a piece of the new requirement that forces doctors to take part in the educational programming, companies that make drugs like Vicodin will be required to make educational activities available. This combines with the requirements for education that have been in place since 2012 for the makers of long-acting opioids like OxyContin.

 According to a recent report about the FDA changes:

“The Food and Drug Administration is requiring manufacturers of the most widely prescribed painkillers to provide extensive training to doctors in an attempt to reduce the number of patients who become addicted, and stem the ongoing opioid crisis.
The agency notified 74 manufacturers of so-called immediate-release opioids this week that their drugs will now be subject to the tougher requirements, although doctors would not be compelled to take part in the training.
The medications, which include Vicodin and Percocet, often combine oxycodone or hydrocodone with less powerful painkillers like acetaminophen. They account for 90 percent of all opioid painkillers prescribed.
Manufacturers of long-acting opioids such as OxyContin, which release their doses over 12 hours or more, have been subject to the requirements since 2012.”

Current numbers show alarming misuse of opioids.

Current numbers show alarming misuse of opioids.

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It seems that this push for education on the part of doctors who write scripts for the often abused set of drugs is a big step towards slowing down the epidemic. During a press conference about the new requirements, there seemed to be little question about how dangerous this class of drug is. FDA Commissioner Scott Gottlieb spoke at great lengths about the “…immediate-release versions a potential gateway to addiction.”

The current stance of the FDA also seems to signal a new focus as far as curbing current addiction rates. The focus is no longer on illegal drugs or street drugs but instead working with both drug makers and doctors to use the drugs for their intended purpose. Dr. Andrew Kolodny, founder of Physicians for Responsible Opioid Prescribing, has been a long time advocate for opioid reform and controls. As Dr. Kolodny explained to “…have the head of the FDA talk about addiction caused by medical treatment suggests a change in what we hear about opioids.”

At least some of the drugs that are produced legally end up on the street.

At least some of the drugs that are produced legally end up on the street.

While the new educational requirement may help in creating materials that show the dangers of opioids, currently there is no obligation for doctors to participate. Gottlieb hinted that this requirement is something that the steering community may push for in the near future. As Gottlieb shared, the FDA is also discussing “…whether there are circumstances when FDA should require some form of mandatory education for healthcare professionals, and how the agency would pursue such a goal.”

Educational requirements can help correct accidental misuse and doctors who may not fully understand the best practices for short-term use of painkillers. This type of programming does not, however, addresses doctors that in some cases profits from this kind of addiction. There have been a handful of doctors arrested for writing massive amounts of scripts for this class of drug simply to make a profit from their customers’ addiction. In those cases, it seems those doctors are well aware of the dangers associated with addiction.